MDR-01-02

Family-consent heart model, 1:1

نموذج قلب للموافقة العائلية

Offered in year 1

Open the door. Invoice services and non-device models. No EDA device file yet.

A one-to-one congenital or structural heart the team can hold while explaining the operation. Billed as a hospital service.

A demonstration segmentation, not a Smouha patient. The coronaries, sinuses of Valsalva, leaflets, aorta, ventricles, atrium and myocardium are separated before anyone prints a model. That is how a clinician sees the anatomy, checks whether a device can fit, and meets the difficult part of the case before the operating room.
A four-chamber heart in a clear tank, with arteries and veins. This is the shape of a structural planning model. Photograph from a silicone-simulator catalogue (Ningbo Trando). It shows the class of model AEDTH is building toward. It was not made at Smouha, and it is not a supplier selected for purchase.

Regulatory posture: Not a medical device. For planning, rehearsal or training. Not for diagnosis or implantation.
Who it is for: Families and congenital teams
Kind: Planning model
Limit: Does not replace imaging review or consent forms.

What is in the line